First-in-Class Cholesterol Rx Approved

Praluent (alirocumab), from Sanofi-Aventis and Regeneron, approved to treat high cholesterol by FDA

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) A first-in-its-class injectable cholesterol medication just received the US Food and Drug Administration's (FDA) seal of approval.

The FDA today approved Praluent (alirocumab) to treat high cholesterol. The Sanofi-Aventis and Regeneron Pharmaceuticals drug is the first in a new class of injectable, cholesterol-lowering drugs.

“Praluent provides another treatment option for patients with [high cholesterol] or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough on statins,” said John Jenkins, MD, director of the Office of New Drugs, Center for Drug Evaluation and Research, in a press release. “The FDA strongly supports continued work to provide new and innovative options for the treatment and prevention of cardiovascular disease.”

Praluent is only approved to be used along with a healthy diet and statins, a common type of high cholesterol drug. It is not approved for children.

While not all cholesterol is bad, the "bad" type, or low-density lipoprotein (LDL), has been linked to heart disease — one of the most common fatal health problems in the US.

But the new drug is thought to fight high LDL cholesterol by targeting the PCSK9 protein. This protein reduces the liver's ability to remove LDL cholesterol from the body. When Praluent attacks this protein, the liver can remove more of the bad cholesterol.

This FDA approval comes after five studies involving nearly 2,500 total patients found that Praluent was safe and effective. On average, the patients taking Praluent in these studies saw their LDL cholesterol levels drop by 36 to 59 percent, according to the FDA.

Side effects of Praluent included itching, pain, swelling, bruising, and infections of the nose and throat. Some patients also reported allergic reactions.

Review Date: 
July 24, 2015
Last Updated:
July 31, 2015